NCT03134534

Brief Summary

Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

6 years

First QC Date

April 15, 2017

Last Update Submit

October 28, 2023

Conditions

Pulmonary Neoplasm

Keywords

lobectomyrobot-assisted thoracoscopic surgerylung cancer

Outcome Measures

Primary Outcomes (2)

  • 3-year overall survival (OS)

    OS at 3 year after surgery

    3 year after surgery

  • Lymph node counts

    overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station

    postoperative in-hospital stay up to 30 days

Secondary Outcomes (13)

  • 3-year disease-free survival (DFS)

    3 year after surgery

  • 1-year overall survival (OS)

    1 year after surgery

  • 1-year disease-free survival (DFS)

    1 year after surgery

  • R0 rate

    postoperative in-hospital stay up to 30 days

  • margin state

    postoperative in-hospital stay up to 30 days

  • +8 more secondary outcomes

Other Outcomes (1)

  • total hospitalization expenditures

    postoperative in-hospital stay up to 30 days

Study Arms (2)

VATS group

OTHER

Surgical procedure: VATS lobectomy

Procedure: VATS lobectomy

RATS group

OTHER

Surgical procedure: RATS lobectomy

Procedure: RATS lobectomy

Interventions

VATS lobectomyPROCEDURE

a minimal invasive surgical types for NSCLC: VATS lobectomy

VATS group
RATS lobectomyPROCEDURE

a minimal invasive surgical types for NSCLC: RATS lobectomy

RATS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgical indication for lobectomy;
  • minimal invasive surgery;
  • ASA (American Society of Anesthesiologists) stage: I-III;
  • sign the informed consent. -

You may not qualify if:

  • benign tumor or nodule;
  • present of other malignancy;
  • preoperative chemotherapy, radiotherapy, targeted therapy. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location

Related Publications (4)

  • Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161.

    PMID: 40658465DERIVED

  • Niu Z, Cao Y, Du M, Sun S, Yan Y, Zheng Y, Han Y, Zhang X, Zhang Z, Yuan Y, Li J, Zhang Y, Li C, Han D, Du H, Guo W, Chen K, Xiang J, Zhu L, Che J, Hang J, Ren J, Lerut T, Abbas AE, Lin J, Jin R, Li H. Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial. EClinicalMedicine. 2024 Jul 12;74:102707. doi: 10.1016/j.eclinm.2024.102707. eCollection 2024 Aug.

    PMID: 39105193DERIVED

  • Jin R, Zhang Z, Zheng Y, Niu Z, Sun S, Cao Y, Zhang Y, Abbas AE, Lerut T, Lin J, Li H. Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial. Chest. 2023 Jun;163(6):1576-1588. doi: 10.1016/j.chest.2022.12.037. Epub 2023 Jan 5.

    PMID: 36621757DERIVED

  • Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.

    PMID: 33938492DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • He-Cheng Li, doctor

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2017

First Posted

May 1, 2017

Study Start

June 1, 2017

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

CN(1)